MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

Model Number 201-90411

Device Problem Obstruction of Flow (2423)

Patient Problem Thrombus (2101)

Event Date 05/25/2019

Event Type  Injury  

Manufacturer Narrative

The referenced motor is reported under mfr.Report #2916596-2019-02670.The referenced blood pump is reported under mfr.Report #2916596-2019-02841.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was supported by the centrimag system.It was reported that they heard a sound from the motor and blood pump as if it ingested a clot or was de-coupled.Then the display on the console started flashing and went blank.The console was hooked up to mag monitor so they were able to see pump speed and flows.The patient was switched to backup console and motor with out any complications.After they switched they turned on the console with the blank screen and the issue was resolved and the console had a visual display.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag 2nd gen primary console (serial number (b)(6)) was not returned for analysis.Multiple attempts to obtain the product were unsuccessful.As a result, the reported event could not be confirmed and the root cause could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.The 2nd generation centrimag system operating manual (doc.(b)(4)) has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console, and place the blood pump in the back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8696529
• MDR Text Key: 147924420
• Report Number: 2916596-2019-02669
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6709976
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 74